Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT06305260
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-20
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidural Redirects', 'timeFrame': 'Day of Epidural', 'description': 'Total number of epidural needle redirections'}], 'secondaryOutcomes': [{'measure': 'Total time to epidural space', 'timeFrame': 'Day of Epidural', 'description': 'Total time to epidural space observed via loss of resistance.'}, {'measure': 'Number of attempts at a different level', 'timeFrame': 'Day of Epidural', 'description': 'Number of attempts at a different lumbar level.'}, {'measure': 'Epidural replacement rate', 'timeFrame': 'Day of Epidural', 'description': 'Includes epidurals that needed to be replaced because of failed epidural or inadequate pain relief'}, {'measure': 'Patient satisfaction', 'timeFrame': '24 hours post-epidural', 'description': "Patient's satisfaction with epidural experience observed by a survey in post-partum"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor Epidural'], 'conditions': ['Obesity, Morbid', 'Labor Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \\>40) obstetric patient population. The main questions it aims to answer are:\n\n* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?\n* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study is only being completed in pregnant patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* English Speaking\n* BMI (Body Mass Index) \\> 40\n* Ability to provide informed consent and verbally disclose their medical history\n\nExclusion Criteria:\n\n* History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement\n* Patients with platelet counts \\<70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.\n* Minors\n* Adults unable to make their own decisions or with cognitive issues or developmental delays\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT06305260', 'acronym': 'LOTUS', 'briefTitle': 'LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40', 'organization': {'class': 'OTHER', 'fullName': 'MetroHealth Medical Center'}, 'officialTitle': 'The LOTUS Trial: Lumbar Ultrasound Utility in Obstetric Patients With BMI > 40', 'orgStudyIdInfo': {'id': 'STUDY00000324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional Lumbar Palpation', 'description': 'This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'Pre-procedural Lumbar Ultrasound', 'description': 'This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement.', 'interventionNames': ['Diagnostic Test: Lumbar Ultrasound']}], 'interventions': [{'name': 'Lumbar Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Investigators will utilize our ultrasound machine to complete a pre-procedural lumbar ultrasound prior to epidural placement.', 'armGroupLabels': ['Pre-procedural Lumbar Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}